Cleared Traditional

K921609 - VISTA HP/HPQ SYSTEM

K921609 is the FDA 510(k) clearance for VISTA HP/HPQ SYSTEM by Philips Medical Systems (Cleveland), Inc.. It is a Class 2 Radiology device (product code LNH) cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K921609 · Philips Medical Systems (Cleveland), Inc. · Radiology device
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Jun 1992
Decision
73d
Days
Class 2
Risk

K921609 is an FDA 510(k) clearance for the VISTA HP/HPQ SYSTEM. Classified as System, Nuclear Magnetic Resonance Imaging (product code LNH), Class II - Special Controls.

Submitted by Philips Medical Systems (Cleveland), Inc. (Highland Heights, US). The FDA issued a Cleared decision on June 15, 1992 after a review of 73 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1000 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Philips Medical Systems (Cleveland), Inc. devices

Submission Details

510(k) Number K921609 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 1992
Decision Date June 15, 1992
Days to Decision 73 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
34d faster than avg
Panel avg: 107d · This submission: 73d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LNH System, Nuclear Magnetic Resonance Imaging
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1000
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - LNH System, Nuclear Magnetic Resonance Imaging

All 817
Devices cleared under the same product code (LNH) and FDA review panel - the closest regulatory comparables to K921609.
VISTA HPQ SYSTEM
K921881 · Philips Medical Systems (Cleveland), Inc. · Jul 1992
MRT-50A QD SPINE COIL
K921720 · Toshiba America Mri, Inc. · Jul 1992
MRT-150 QD KNEE COIL
K920096 · Toshiba America Mri, Inc. · Jul 1992
ACCESS QD HEAD COIL
K920098 · Toshiba America Mri, Inc. · Jun 1992
MAGNETIC RESONANCE DIAGNOSTIC DEVICE ACCESSORIES
K920094 · Siemens Medical Solutions USA, Inc. · May 1992
MAGNETOM 63SP
K921098 · Siemens Medical Solutions USA, Inc. · May 1992